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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reamer
Regulation Description Orthopedic manual surgical instrument.
Product CodeHTO
Regulation Number 888.4540
Device Class 1


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ONYX MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 3
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fracture 35
Break 16
Unknown (for use when the device problem is not known) 9
Malfunction 9
Device, or device fragments remain in patient 7
Other (for use when an appropriate device code cannot be identified) 5
Device, removal of (non-implant) 4
No Information 3
Metal shedding debris 2
Difficult to remove 2
Size incorrect for patient 1
Tip breakage 1
Component(s), broken 1
Foreign material 1
Difficult to insert 1
Total Device Problems 97

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 1 1 1 1 4 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Dec-04-2012
2 Biomet, Inc. II Mar-04-2011
3 DePuy Mitek, Inc., a Johnson & Johnson Co. II Dec-17-2012
4 Extremity Medical LLC II Nov-26-2012
5 Sterilmed Inc II Jan-13-2009
6 Stryker Howmedica Osteonics Corp. II May-17-2012
7 Stryker Howmedica Osteonics Corp. II Feb-17-2010
8 Stryker Howmedica Osteonics Corp. II Aug-27-2008

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